Natco Pharma's partner Mylan Inc gets USFDA nod for cancer drug

The company's marketing partner Mylan Inc has received a tentative approval from the United States Food and Drug Administration (USFDA) for abbreviated new drug application (ANDA) for Sorafenib tablets in the strength of 200 mg, Natco Pharma said in a filing to BSE.

NEW DELHI: Natco Pharma today said its marketing partner Mylan Inc has received tentative approval from the US health regulator for selling generic Sorafenib tablets used for treatment of cancer in the American market.

The company's marketing partner Mylan Inc has received a tentative approval from the United States Food and Drug Administration (USFDA) for abbreviated new drug application (ANDA) for Sorafenib tablets in the strength of 200 mg, Natco Pharma said in a filing to BSE.

"Natco and Mylan have filed an ANDA containing a Paragraph IV certification for this product," it added.

The company manufactures this product at its Kothur facility in Telangana, Natco Pharma said.

Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc and Onyx Pharmaceuticals Inc sell Sorafenib tablets, 200mg under the brand name 'Nexavar' in the U S market, it added.

"For the 12 months ending December 31, 2015, Nexavar had U S sales of approximately USD 300 million," Natco said quoting Bayer's Annual Report.

Nexavar is indicated for the treatment of certain types of cancers "including unresectable hepatocellular carcinoma and advanced renal cell carcinoma", it added.